Details for: METRONIDAZOLE
Company: AA PHARMA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 00545066 | METRONIDAZOLE | METRONIDAZOLE | 250 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
METRONIDAZOLE is used to treat infects that are caused by certain bacteria.
Antibacterial drugs like METRONIDAZOLE treat only bacterial infections. They do not treat viral infections.
What it does
METRONIDAZOLE works to:
- Stop growth of bacteria.
- Kill the bacteria.
- Reduce the infection in your body.
When it should not be used
What the medicinal ingredient is
Tablets:
Medicinal: metronidazole
Capsules:
Medicinal: metronidazole
What the non-medicinal ingredients are
Tablets:
Non-medicinal: colloidal silicon dioxide, croscarmellose sodium, magnesium
stearate and microcrystalline cellulose.
Capsules:
Non–medicinal: croscarmellose sodium, colloidal silicon dioxide and stearic acid.
The capsule shell: gelatin, D&C red #33, D&C yellow #10, FD&C blue #1, FD&C green #3, talc and titanium
dioxide. The edible ink: black iron oxide, shellac glaze, propylene glycol, FD&C blue #2, and FD&C red
#40.
What dosage form it comes in
METRONIDAZOLE comes in the following dosage forms:
- Metronidazole Tablets 250 mg
- Metronidazole Capsules 500 mg
Warnings and precautions
Serious Warnings and Precautions
Do not use METRONIDAZOLE if:
- you are allergic to metronidazole, nitroimidazoles (e.g. tinidazole) or any of the ingredients in METRONIDAZOLE (see What are ingredients in METRONIDAZOLE).
- you have a disease of the nervous system.
- you have a history of blood disease, hypothyroidism (underactive thyroid gland) or hypoadrenalism (underactive adrenal glands).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take METRONIDAZOLE. Talk about any health conditions or problems you may have, including if you:
- are pregnant, think you are, or plan to get pregnant
- are breastfeeding, or planning to breastfeed, as metronidazole is excreted in human breast milk.
- have liver problems
- have any blood disorder (e.g. leukemia, hemophilia, or other). Your doctor may order periodic blood tests.
Other warnings that you should know about:
You may feel dizzy or experience confusion while taking METRONIDAZOLE. Do not drive or operate heavy machinery if you experience any of these side effects.
Interactions with this medication
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with METRONIDAZOLE:
- Corticosteroids – used to treat allergies, skin problems, asthma and arthritis
- Disulfiram – used to treat alcoholism
- Lithium – used as a psychiatric medication
- Phenytoin – used to treat seizures
- Phenobarbital – used to treat insomnia, anxiety or tension
- Warfarin – a blood thinner used treat heart conditions
- 5-fluorouracil - used to treat cancer
Do not drink alcohol while taking METRONIDAZOLE.
METRONIDAZOLE may interfere with certain medical tests. Tell your healthcare professional that you are
taking METRONIDAZOLE if you are given a test.
Proper use of this medication
How to take METRONIDAZOLE:
- Although you may feel better early in treatment, METRONIDAZOLE should be used exactly as directed.
- Misuse or overuse of METRONIDAZOLE could lead to the growth of bacteria that will not be killed by METRONIDAZOLE (resistance). This means that METRONIDAZOLE may not work for you in the future.
- Do not share your medicine.
Usual Dose
Your doctor will decide how much METRONIDAZOLE you should take depending on the type of infection you have. The usual dose is 250 mg - 500 mg every 8 – 12 hours for 5 – 7 days.
Overdose
If you think you have taken too much METRONIDAZOLE, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
Missed Dose
If you forget to take METRONIDAZOLE, take them as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not use a double dose to make up for a forgotten dose.
Side effects and what to do about them
What are possible side effects from using METRONIDAZOLE?
Like all medicines, METRONIDAZOLE can cause side effects, although not everybody gets them.
These side effects may include:
- Unpleasant taste in the mouth
- Dry mouth
- Furred tongue
- Chest pain
- Feeling sick (nausea), being sick (vomiting), upset stomach, stomach pain or diarrhea
- Noise such as buzzing, ringing, or whistling heard in the ear.
- Loss of appetite
- Vaginal dryness or burning
| Symptom / effect | Talk to your healthcare professional only if severe | Talk to your healthcare professional in all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Allergic reaction with symptoms such as swelling of the mouth, throat, hands, difficulty in breathing or swallowing, itching, rash, red spots and blisters | ✔ | ||
| Liver problems including cases of liver failure with symptoms such as intense fatigue, yellowing of the skin and eyes, dark urine, abdominal pain. | ✔ | ||
| Nervous system problems with symptoms such as inability to coordinate voluntary movements, problems using your arms and legs, problems with speaking or feel confused, convulsions, tingling sensation on the skin, stiff neck associated with headache, extreme sensitivity to bright light | ✔ | ||
| Pancreatitis (inflammation of the pancreas) with symptoms such as severe abdominal pain which may reach through to your back, especially associated with nausea, vomiting and fatigue. | ✔ | ||
| Problems with your eyesight such as blurred or double vision | ✔ | ||
| Feeling depressed | ✔ | ||
| Pain in eyes | ✔ | ||
| Mental problems such as feeling confused and seeing or hearing things that are not there (hallucinations) | ✔ | ||
| Numbness, tingling, pain, or a feeling of weakness, in the arms or legs | ✔ | ||
| Hearing loss | ✔ |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by
- Visiting the Web page on Adverse Reaction Reporting www.canada.ca/en/health-canada/services/drugshealth-products/medeffect-canada/adverse-reaction-reporting.html for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice
More information
Read this carefully before you start taking METRONIDAZOLE and each time you get a refill. This leaflet is a summary and will not tell you everything about this drug. Talk to your healthcare professional about your medical condition and treatment and ask if there is any new information about METRONIDAZOLE.
If you want more information about METRONIDAZOLE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this patient medication information by visiting the Health Canada website www.canada.ca/en/health-canada/services/drugs-health-products/drug products/drugproduct-database.html; the manufacturer’s website www.aapharma.ca/products, or bycalling 1-800-667-4708.
All registered trademarks are the property of their respective owners.
This leaflet was prepared by AA Pharma Inc.
Last revised: January 11, 2019